Label: BELLADONNA BETULA FORMICA liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated September 16, 2019

If you are a consumer or patient please visit this version.

  • INDICATIONS & USAGE

    Directions: FOR ORAL USE.

  • DOSAGE & ADMINISTRATION

  • ACTIVE INGREDIENT

    Active Ingredients: Betula e fol. (Silver Birch leaves) 3X, Atropa belladonna ex herba (Nightshade) 6X, Formica ex animale (Red wood ant) 6X

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Salt, Boric acid, Sodium bicarbonate, Rose oil

  • PURPOSE

    Use: Temporary relief of headache.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • WARNINGS

    Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Do not use if safety seal is broken or missing.

    REFRIGERATE AFTER OPENING. USE WITHIN 30 DAYS OF OPENING.
    Opened on:_________________

  • QUESTIONS

    Questions? Call 866.642.2858
    Made by Uriel, East Troy, WI 53120
    www.urielpharmacy.com

  • PRINCIPAL DISPLAY PANEL

    Belladonna Betula FormicaBelladonna Betula Formica 10ml

  • INGREDIENTS AND APPEARANCE
    BELLADONNA BETULA FORMICA 
    belladonna betula formica liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48951-2133
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA6 [hp_X]  in 1 mL
    FORMICA RUFA (UNII: 55H0W83JO5) (FORMICA RUFA - UNII:55H0W83JO5) FORMICA RUFA6 [hp_X]  in 1 mL
    BETULA PENDULA LEAF (UNII: 5HW39H9KDH) (BETULA PENDULA LEAF - UNII:5HW39H9KDH) BETULA PENDULA LEAF3 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BORIC ACID (UNII: R57ZHV85D4)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    ROSE OIL (UNII: WUB68Y35M7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48951-2133-11 in 1 BAG09/01/2009
    110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/01/2009
    Labeler - Uriel Pharmacy Inc. (043471163)
    Establishment
    NameAddressID/FEIBusiness Operations
    Uriel Pharmacy Inc.043471163manufacture(48951-2133)